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Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01786850
Expanded Access Status : Available
First Posted : February 8, 2013
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Alessandro Napoli, University of Roma La Sapienza

Tracking Information
First Submitted Date February 5, 2013
First Posted Date February 8, 2013
Last Update Posted Date June 18, 2014
 
Descriptive Information
Brief Title Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
Brief Summary

Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control.

As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.

Detailed Description Not Provided
Study Type Expanded Access
Intervention Procedure: Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)
High intensity focused ultrasound (HIFU) is a non-invasive ablation technique under ultrasound (US) guidance for the treatment of solid tumors. Differently from other ablations, HIFU induces tissue necrosis through short (10-30s) and relatively low grade (60-80 C°) thermal stimulations. Clinical applications of HIFU include uterine fibroids, prostate, hepatic and breast cancer. Selected patients with pancreatic cancer have been treated with US-guided HIFU for both pain control and tumor debulking. The development of a MR guidance for HIFU (MRgFUS) enabled to perform real-time monitoring and precise control of beam direction, temperature changes and deposited thermal dose beyond the capability of conventional US guidance. This system has been approved for the treatment of uterine fibroids and bone metastases in the United States and European Union. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate ablation modality for unresectable pancreatic cancer.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: alessandro napoli, MD, PhD +390649974540 alessandro.napoli@uniroma1.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01786850
Responsible Party Alessandro Napoli, University of Roma La Sapienza
Study Sponsor University of Roma La Sapienza
Collaborators Not Provided
Investigators
Principal Investigator: alessandro napoli Sapienza University of Rome, Policlinico Umberto I Hospital
Study Chair: carlo catalano Sapienza University of Rome, Policlinico Umberto I Hospital
Study Director: michele anzidei Sapienza University of Rome, Policlinico Umberto I Hospital
PRS Account University of Roma La Sapienza
Verification Date June 2014